BOLTON PTA CATHETER


Device Classification Name

catheter, angioplasty, peripheral, transluminal

510(k) Number K021996
Device Name BOLTON PTA CATHETER
Original Applicant
Bolton Medical, Inc.
16-00 pollitt dr.
fair lawn, 
NJ 
07410

Original Contact vivian kelly
Regulation Number 870.1250
Classification Product Code
LIT  
Subsequent Product Code
DQY  
Date Received 06/18/2002
Decision Date 08/23/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No